The Acist® Angiographic Injection System delivers contrast media to a catheter at a userdetermined variable flow rate that can be instantaneously and continuously varied. The system is comprised of the following elements: Injector Head, Control Panel, Power Supply, AC Power and Interconnect Cables. Not affected by this change, but provided with the system are the sterile disposable components. These are contained in two separate kits (D-1000 and H-1000) and include the Hand Controller, Contrast Syringe, and the valving to provide the interface between the system and the angiographic patient catheter.

AI/ML Overview

I am sorry, but after reviewing the provided document, I cannot find the specific information regarding acceptance criteria and a study that proves the device meets those criteria. The document appears to be a 510(k) summary for the Acist Angiographic Injection System, Model CL100H, focusing on its substantial equivalence to a predicate device and its indications for use.

The document does not contain:

A table of acceptance criteria and reported device performance.
Details on sample sizes used for test sets, data provenance, or the number/qualifications of experts for ground truth.
Information about adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance.
The type of ground truth used, sample size for the training set, or how ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Summary

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K993774

DEC - 7 1999

Image /page/0/Picture/2 description: The image shows the logo for Acist Medical Systems. The logo features the word "acist" in bold, black letters, with a stylized design above the "i" that resembles a small circle with a line extending from it. Below "acist" are the words "MEDICAL SYSTEMS" in a smaller, sans-serif font. A curved line is above the word "acist".

510(k) SUMMARY

Applicant's Name and Address:

Acist Medical Systems, Inc. 7450 Flying Cloud Drive Suite 150 Eden Prairie, MN 55344

Name of Contact Person:

Carl M. Beaurline Vice President, Quality Assurance / Regulatory Affairs

Telephone and Fax Numbers:

Telephone - (612) 995-9319 Fax - (612) 941-4648

Address of Manufacturing and Sterilization Site:

Manufacturing: Acist Medical Systems, Inc. 7450 Flying Cloud Drive Suite 150 Eden Prairie, MN 55344

Sterilization: Not applicable to this product.

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Acist® Angiographic Injection System, Model CL100H Proprietary Name:

Common Name: Contrast Injector

Classification Name: Injector, Contrast Medium, Automatic

Classification Number: 870.1650

Class: II

Classification Panel: Cardiovascular

Product Code: IZO

Description:

The Acist® Angiographic Injection System delivers contrast media to a catheter at a userdetermined variable flow rate that can be instantaneously and continuously varied.

The system is comprised of the following elements:

Injector Head
Control Panel .
Power Supply
AC Power and Interconnect Cables ●

Not affected by this change, but provided with the system are the sterile disposable components. These are contained in two separate kits (D-1000 and H-1000) and include the Hand Controller, Contrast Syringe, and the valving to provide the interface between the system and the angiographic patient catheter

Predicate Device: Acist® Angiographic Injection System, Model CL100H without the "RESUME" feature.

Indications for Use:

The Acist Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 1999

Mr. Carl M. Beaurline Vice President, Quality Assurance/Regulatory Affairs Acist Medical Systems, Inc. 7450 Flying Cloud Drive Eden Prairie, MN 55344

K993774 Re: Trade Name: Acist Angiographic Injection System Regulatory Class: II Product Code: DXT Dated: November 4, 1999 November 8, 1999 Received:

Dear Mr. Beaurline:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to

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Page 2 - Mr. Carl M. Beaurline

your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Chistopher M. Heaton

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 6 - STATEMENT OF INDICATIONS FOR USE / LABELING

PART A - INDICATIONS FOR USE FORM

Page _________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number:

Device Name: Acist Angiographic Injection System

Indications for Use:

The Acist Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of I

Christopher tu White

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.